Toxicological evaluation in the context of REACH
Do you want to perform a toxicological evaluation according to the REACH regulation?
Since Regulation 2016/863, manufacturers or importers of medical devices containing chemical substances are obliged to place on the market substances that do not have harmful effects on human health or the environment. The REACH Regulation excludes from this obligation medical devices that are invasive or used in direct physical contact with the human body.
Toxicological evaluation tests must be done in vitro as a first step.
However, in vivo tests can be used as a second recourse, when the results of in vitro tests are not conclusive and no in vivo data is available on the product.
FILAB laboratory assists you in performing the toxicological evaluation according to REACH requirements
With the support of a partner laboratory, FILAB assists you in the toxicological analysis of your medical devices according to REACH, and more generally in the biological evaluation of your medical devices:
- Cytotoxicity test according to ISO 10993-5
- Toxicological evaluation of leachable substances according to ISO 10993-17
- Skin irritation and sensitization test according to ISO 10993-10
- Chemical characterization according to ISO 10993-18
- Degradation study according to ISO 10993-13 / -14 / -15
- Identification of chemical substances REACH
- Deformation
- R&D support: assistance in the development of new formulas
Our human size, our permanent investments and our knowledge of the medical devices sector guarantee our customers reliable results, rapid processing of requests and tailor-made support for their needs.
